MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CARBON DIOXIDE

Catalog Number 03L80-21

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported of falsely depressed architect carbon dioxide results for multiple samples.The customer indicated the initial results were approximately 18 mmol/l and retested on a new lot with a results of approximately 22 mmol/l.There was no reported impact to patient management.

Manufacturer Narrative

Review of complaint activity determined that there were no other complaints related to falsely depressed results for the likely cause lot.Tracking and trending report review for the carbon dioxide assay determined that there were no related adverse or non-statistical trends.The customer's instrument logs were reviewed.This review found the absorbances for the last calibration with the likely cause lots were lower than previous calibrations, which may indicate possible contamination of the carbon dioxide reagent.Using world wide field data the performance of reagent lot 53082uq05 and calibrator lot 11449fd01 were reviewed and no issues were identified.Manufacturing documentation for the assay was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect carbon dioxide assay was identified.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8112107
• MDR Text Key: 129353260
• Report Number: 1628664-2018-02068
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740005955
• UDI-Public: 00380740005955
• Combination Product (y/n): N
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 03L80-21
• Device Lot Number: 53082UQ05
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT C8000 SYSTEM, LIST 01G06-11,; ARCHITECT C8000 SYSTEM, LIST 01G06-11,; SERIAL (B)(4) ; SERIAL (B)(4)